Ignite Creation Date:
2024-05-06 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03585374
Status:
COMPLETED
Last Update Posted:
2019-05-09
First Post:
2018-05-31
Brief Title:
Trauma Acute Pain Treatment With Methoxyflurane Vaporized PENTHROX Efficacy and Safety Study MEDITA
Sponsor:
Mundipharma Pharmaceuticals srl
Organization:
Mundipharma Pharmaceuticals srl
Study Overview
Official Title:
Efficacy and Safety of Methoxyflurane Vaporized PENTHROX in the Treatment of Acute Trauma Pain in Pre-hospital Setting and in the Emergency Department in Italy a Multicentre Randomized Controlled Open-label Study
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEDITA
Brief Summary:
The prompt treatment of pain due to minor trauma is often an unmet need in both Emergency Room Department and Ambulance Rescue Most of the available drugs are intravenously administered and such route of administration may account for delay in the pain relief onset
Methoxyflurane is an halogenated anesthetic self-administered by the patient at sub-anesthetic dose through an easy to handle inhaler Penthrox The efficacy and safety of Penthrox in the treatment of acute traumatic pain will be investigated in an out-of-hospital and in hospital emergency medical care setting
Methoxyflurane is an halogenated anesthetic self-administered by the patient at sub-anesthetic dose through an easy to handle inhaler Penthrox The efficacy and safety of Penthrox in the treatment of acute traumatic pain will be investigated in an out-of-hospital and in hospital emergency medical care setting
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None